Product Quality Lead
Job TitleProduct Quality Lead
Product Quality Lead, Healthcare (Highland Hts, OH)
- Oversee Quality Assurance in the process related to the manufacturing of materials, components, sub-assemblies and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated prodcuts/businesses
- Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive compliance to Quality System Requirements (QSRs) and company procedures.
- Provides leadership and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members
- Ensures that appropriate quality plans are made and a suitable quality system is in place, for both NPI’s as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System design
- Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems
- Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.)
- Review calibration plans and records, environmental controls, and training plans and records
- Organize IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls
- Approve which processes need validation/re-validation after changes, and verify processes and plans/records
- AS degree in QA, Engineering or related field OR equivalent (i.e. high school diploma, GED plus 2 years working experience, within QA engineering in the medical device industry)
- 3-5 years of experience in the following
- Leadership role
- Demonstrated ability to develop and lead process implementation and improvement in a team environment
- Working knowledge of Control of Nonconforming Product activities and requirements
- Experience with CAPA processes including investigational techniques
- Working knowledge of medical device regulations (including FDA QSRs, ISO13485)
At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips’ dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Find out more info about Philips at www.philips.com/na/careers
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